Abstracts A45 sores), and medication-related risks (liver failure, blood clot). OS was held constant at 32 months. Trade-off questions were based on predetermined experimental design with known statistical properties. Random-parameters logit model was used to esti- mate a preference weight for each attribute level. Preference weights were used to calculate maximum levels of risks patients were willing to accept for increases in PFS. RESULTS: A total of 138 US subjects completed the survey. PFS was the most impor- tant attribute to patients over the range of levels included in the survey, while remain- ing attributes were ranked in order of importance as: fatigue, diarrhea, liver failure, hand-foot syndrome, blood clot, mouth sores. Increasing PFS by 10 months was as important as avoiding severe fatigue and 2-times as important as avoiding severe mouth sores. Patients were willing to accept blood-clot risks up to 5.5% (95% CI: 3.6%–8.6%) and liver-failure risks up to 3.6% (95% CI: 2.6%–4.8%) to increase PFS by 10 months. CONCLUSIONS: PFS is a clinical outcome that is important to RCC patients. Patients were willing to accept higher treatment-related risks to increase PFS. PCN111 PRO LABELLING CLAIMS IN ANTINEOPLASTIC AGENTS Caron M, Emery MP MAPI Research Trust, Lyon, France OBJECTIVES: To review PRO labelling claims achieved in antineoplastic products in Europe and in the US. METHODS: PROLabels database was searched with neoplasm and oncology as keywords to identify antineoplastic agents with PRO labeling claims approved or revised in Europe since 1995 and in the US since 1998. FDA and EMEA websites and guidances were reviewed. Anti-emetic and analgesic products were not included. RESULTS: Among the 101 antineoplastic products approved, 18 were identified with PRO claims—10 in the U.S, 8 in Europe (including one in both agen- cies)—for 11 different indications: non-small cell lung carcinoma, prostatic neoplasms, small cell lung carcinoma, Kaposi sarcoma, chronic myeloid leukemia, astrocytoma, pleural malignant mesothelioma, breast neoplasms, head & neck neoplasms, stomach neoplasms and colorectal neoplasms. Survival was primary endpoint for 12 products. Other primary endpoints included time to progression, response rate and response duration. PROs included in labels were primary endpoints in only two cases: one product used in prostatic neoplasms (improvement in pain) and one product approved for pancreatic neoplasms (clinical benefit response including pain intensity, use of rescue medication and performance status). Both products were approved by the FDA. Health-related quality of life was clearly mentioned in the label of 7 products (4 approved by the EMEA including 2 approved after the publication of the EMEA and FDA guidances, and 3 by the FDA, all approved before the publication of the guid- ances). Of these 7 products, 3 approved by the EMEA and 1 by the FDA had an indication for non-small cell lung carcinoma. CONCLUSIONS: PROs are rarely used as primary endpoints in approval of antineoplastic agents except for assessing pallia- tive response. When assessed, health-related quality of life is used as a supportive endpoint, and more often associated with non-small cell lung carcinoma, especially in Europe. PCN112 LITERATURE REVIEW AND PRODUCT LABEL CLAIM REVIEW FOR THE DEVELOPMENT OF A PATIENT-REPORTED OUTCOME RESEARCH STRATEGY FOR CANCER-RELATED ANEMIA Hackshaw MD, Brown J Eli Lilly and Company, Indianapolis, IN, USA OBJECTIVES: An appraisal of patient-reported outcome (PRO) endpoints and exist- ing instruments to measure such endpoints was conducted to identify and critically review potentially relevant and appropriate instruments for use in clinical trials of cancer-related anemia (CRA). The purpose of the study was to determine what PRO endpoints and instruments have been used to assess the impact of treatment in reduc- ing CRA symptoms, and whether the instruments identified were likely to be of the standard acceptable by regulatory authorities to support a label claim. METHODS: A systematic search and review of 1486 published scientific abstracts was conducted using MEDLINE and EMBASE, as well as the supporting statements in regulatory agency labels for drugs used in the treatment of anemia. Consistency of the identified PRO measures and their psychometric properties with the current Food and Drug Administration (FDA) draft guidance on PROs supporting a labeling claim was also evaluated. RESULTS: A total of 29 instruments were identified. Four instruments were found to support a label claim or used specifically in the CRA population (FACT-F, FACT-An, CLAS/LASA, EORTC QLQ-C30); these were assessed further. Twenty-five were excluded from further assessment because they were specific to a particular disease other than cancer and covered aspects specific to these diseases which were not relevant to the CRA population. Other exclusion reasons included measurement of general health or health-related quality of life (HRQOL) and other symptoms that were neither specific to cancer nor anemia. CONCLUSIONS: None of the four instru- ments assessed were found to meet all the criteria in the FDA draft guidance; however, the findings help inform the design of new PRO instruments for CRA. PCN113 HEALTH RELATED QUALITY OF LIFE, FEAR OF RECURRENCE, IMPACT OF EVENTS, ILLNESS INTRUSIVENESS AND PSYHOLOGICAL DISTRESS IN NON-MUSCLE INVASIVE BLADDER CANCER PATIENTS Sansgiry S 1 , Lerner SP 2 , Amiel GE 2 , Mei M 1 , Latini DM 1 1 Baylor College of Medicine; Health Services Research & Development Center of Excellence, Michael E. DeBakey VA Medical Center, Houston, TX, USA, 2 Baylor College of Medicine, Houston, TX, USA OBJECTIVES: The purpose of this study was to explore differences among Veterans and private-patients on health related quality of life (HRQOL), fear of recurrence (FOR), impact of events (IE), illness intrusiveness (IITF) and psychological distress in non-muscle invasive bladder cancer (NMIBC) patients and provide direction for further study. METHODS: Cross sectional study design was used. Participants were drawn from a large private hospital (N = 38) and Veterans Affairs hospital (N = 29) in the southeast United States. HRQOL was measured with EORTC-QLQ-C30. FOR was measured with 5-item measure used in the Cancer of the Prostate Strategic Research Endeavor study. The IE Scale measures subjective response to stress and consists of two subscales, intrusive thoughts and avoidance. The IITF measure assesses impact of illness on functioning and consists of three subscales, intimacy, instrumental life and relationship-personal development. Psychological distress was measured with the Brief Symptom Index (BSI), an 18-item measure. Differences among Veterans vs. private-patients were assessed with student t-test or chi-square as appropriate. Analy- ses were performed using the SAS v9.1.3. RESULTS: Majority of respondents were older (mean age at diagnosis 65.4(± 8.8) years), white (91.1%), males (83.6%), married (70.2%) and largest percentage (35.8%) reported getting some college educa- tion. Veterans group did not differ from private-patients on age, education, ethnicity, relationship status, number of bladder cancer treatments received or time since diag- nosis (years) (p > 0.05), but differed significantly on gender (p = 0.0016). Number of comorbidities were also higher in the Veterans group (p = 0.0214). Veterans indicated significantly higher FOR, psychological distress, illness intrusiveness on intimacy and instrumental life, and lower HRQOL compared to private-patients (p < 0.05). CON- CLUSIONS: Veterans had higher level of FOR and psychological distress but lower HRQOL, than private-patients. Interventions to manage patients’ fear of recurrence, psychological distress and help them adapt to altered routine may assist NMIBC patients. PCN114 EXPLORING THE BURDEN OF ILLNESS ON NEWLY DIAGNOSED ESOPHAGEAL CANCER PATIENTS IN TAIWAN –PRELIMINARY ANALYSIS Lin HW, Ku CH, Lee RF, Shih TP, Liu YY, Lin CY China Medical University, Taichung, Taiwan OBJECTIVES: Esophageal cancer (EC) is the seventh cancer among male patients in Taiwan. Difficulty swallowing makes EC patients vulnerable to nutritional challenges and impacts their treatment outcomes and well-being. The aims of this study are to explore the EC patients’ burden of illness on nutritional and well-being aspects. METHODS: A longitudinal observation study is conducting to recruit newly diag- nosed EC patients from the CMU Hospital in Taichung, Taiwan since June 2009. Fresh EC patients were assessed before (T0) and after receiving any main treatments (T1 [1-month], T2 [3-month], T3 [6-month] after treatment(s)) if it is not impossible. Well trained interviewers solicited patients’ responses on 1) Nutritional Risk Screen (NRS-2002); 2) Chinese versions of EQ-5D and FACT-E. The descriptive analyses were performed to examine the trends among different stages of EC patients. RESULTS: Up to the date of analysis(December 31, 2009), of 27 recruited EC patients, average age was 53 ± 9 years-old and more than 90% were diagnosed with squamous cell carcinoma (³85% with clinical stage at III and above). There were 23, 14, 5 and 2 patients completed the T0, T1, T2 and T3 assessments, respectively. Approximately 70% and 80% of patients at T0 and T2 had NR-2002S scored greater than 3 (with defined risk of malnutrition). From T0 to T3, upon the solicited, completed responses, patients seemed to be deteriorated on the daily activities and social well-being (i.e., self-care, usual activity of EQ-5D, and physical and social well-being of FACT-E) but improve on esophageal cancer related symptoms and signs (additional concerns of EC) after treatments. CONCLUSIONS: This preliminary analysis showed the extent of EC patients’ burden of illness and its change over time. Further assessments are necessary to facilitate the decision making about appropriate management of EC patients on the aspect of nutrition and health-related quality of life. PCN115 HEAD-TO-HEAD COMPARISONS OF QUALITY OF LIFE INSTRUMENTS FOR YOUNG ADULT SURVIVORS OF CHILDHOOD AND ADOLESCENT CANCER Huang IC 1 , Quinn G 2 , Shenkman E 1 , Shearer P 1 1 University of Florida, Gainesville, FL, USA, 2 H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA OBJECTIVES: Although several health-related quality of life (HRQOL) instruments exist for adult cancer survivors, little attention has been paid to identify appropriate instruments for young adult survivors of childhood and adolescent cancer (YASCAC). We aim to make head-to-head comparisons of 3 HRQOL instruments for YASCAC. METHODS: We collected data via telephone interviews between 05/01/2009 and 09/30/2009 from 141 YASCAC who were off therapy at least 2 years without cancer and enrolled in the CSP and/or the UF Tumor Registry. Each subject reported his/her late effects (yes/no) and HRQOL. HRQOL was measured using the Quality of Life